MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 79/83X10; PROSTHESIS, KNEE

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 05/31/2018

Event Type  Injury  

Event Description

It was reported the patient underwent a right knee procedure.Subsequently, the patient was revised six years, two months post implantation due to a failed bearing.At the time of that surgery, the bearing was the only thing replaced.Additional information requested from patient but patient has not responded to multiple contact attempts.No additional information available.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.This complaint was not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: E1 VNGD PS TIB BRG 79/83X10
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13090031
• MDR Text Key: 285172635
• Report Number: 0001825034-2021-03479
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: EP-183660
• Device Lot Number: 982480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 113 KG